Kornimate/medical-research-clean huggingface dataset:
alliance of randomized trials of medicine vs metabolic surgery in type 2 diabetes

Conditions: Type 2 Diabetes Mellitus; Obesity

Summary: initially, 4 teams of investigators conducted randomized controlled trials (rct) at their own site to evaluate the effectiveness of bariatric surgery compared to medical/lifestyle management of type 2 diabetes. each study followed subjects for a duration of about 1 - 3 years. following this, a consortium was created to pool data and continue to follow study participants. this early collaboration of the 4 groups of investigators was supported by industry sponsors (ethicon, inc and medtronic-mitg). now, the investigators have successfully received a grant from the nih, as the sole supporter of continued observational follow-up of study participants. the continuing aim of this study is to combine data from the 4 studies and follow the original randomized subjects for an additional 5 years of follow-up. the purpose of the study is to determine the longer term durability and effectiveness of bariatric surgery compared to medical/lifestyle intervention on the treatment of type 2 diabetes.

the four investigative groups initiated their individual rct's at their respective sites to evaluate the effectiveness of bariatric surgery compared to multidisciplinary medical and lifestyle management of diabetes and body weight. the original trials were each designed to assess feasibility over a relatively short duration of follow-up (1-3 years). individually, each trial lacked the sample size and duration of follow-up to meaningfully inform clinical decision making. together, with the funding provided by the nih for longer follow-up, the consortium trial can provide a unique national resource to address timely and unanswered clinical questions related to the durability of these alternative management approaches in patients with t2d and obesity. together, participants from these studies represent the largest cohort with diabetes (one third having a bmi \<35 kg/m2) ever to undergo randomized assignment to bariatric surgical procedure vs. medical/lifestyle intervention.

Eligibility criteria:
inclusion criteria: * original inclusion criteria for participation in the rcts at all sites included: * candidate for general anesthesia or unsupervised exercise. * age ≥20 and ≤65 years. * body mass index \>27 and ≤45 kg/m2. * diagnosis of type 2 diabetes confirmed by either requiring diabetes medication and/or having elevated glycemia based on hba1c, fasting plasma glucose, and/or oral glucose tolerance test (ogtt) results, according to american diabetes association criteria. * ability and willingness to participate in the study and agree to any of the research arms. * able to understand the options and to comply with the requirements of each program. * negative urine pregnancy test at screening and baseline visits (prior to surgery) for women of childbearing potential (i.e., biologically capable of becoming pregnant). exclusion criteria: * subjects who were randomized in one of the four rcts but never initiated intervention / did not receive randomized treatment * refusal to sign informed consent
effects of the myofascial induction technique versus a control laser

Conditions: Foot Diseases; Myofascial Pain

Summary: the objective is to determine the effectiveness of myofascial induction effects on plantar pressures variables. forty healthy subjects will be recruited for a simple blind clinical trial. all subjects will be randomly distributed in two different groups: control group (sham laser) and experimental group (myofascial induction). outcome measurements will be foot plantar pressure area (footprint) by a validated platform. two trials will be recorded before and after intervention in standing position.


Eligibility criteria:
inclusion criteria: * healthy individuals without pain. exclusion criteria: * previous lower extremities surgery * history of lower extremities injury with residual symptoms within the last year * evidence of a leg-length discrepancy of more than 1 cm * evidence of balance deficits
volatile versus propofol anesthesia in opcab

Conditions: Off Pump Coronary Artery Bypass Graft

Summary: off pump coronary artery bypass graft (opcab) still requires myocardial protection owing to intermittent regional ischemic episode. the investigators retrospectively evaluated the cardioprotective and clinical outcomes of propofol versus isoflurane anesthesia in patients undergoing opcab.

several experimental and clinical researches have suggested that volatile anesthetics may reduce mortality in cardiac surgery owing to its preconditioning induced cardioprotective effect. off-pump coronary artery bypass graft (opcab) surgery still requires cardioprotective strategies due to coronary hypoperfusion during anastomosis. the aim of this study was to evaluate the possible cardioprotective effect and clinical outcomes of propofol versus isoflurane anesthesia in patients undergoing opcab using propensity matching.

Eligibility criteria:
inclusion criteria: * opcab exclusion criteria: * on pump conversion

Keywords: ischemic heart disease off pump coronary artery bypass graft isoflurane propofol
physiological changes with spg stimulation in migraine patients

Conditions: Chronic Migraine

Summary: hypothesis: stimulation of the spg at low frequencies (20 hz)is believed to cause a physiological parasympathetic upregulation which increases vmca, concentration and cephalic vessel diameter.


Eligibility criteria:
inclusion criteria: * chronic migraine patients exclusion criteria: -
study to evaluate the effectiveness of cardiac rehabilitation (rehab) for acute decompensated heart failure patients on 6 minute walk test and quality of life

Conditions: Heart Failure

Summary: the aim of the investigators' project is to determine if patients admitted with a primary diagnosis of heart failure to sanford health facilities in regional southeastern south dakota demonstrate benefits in improvement in functional capacity, quality of life, and a reduction in hospital readmission rates from a cardiac rehab program immediately following a discharge for an acute decompensated heart failure diagnosis related inpatient hospitalization encounter. the investigators hypothesize that those that receive cardiac rehab will have improved quality of life and reduced readmission rates at 30 and 90 days.


Eligibility criteria:
inclusion criteria: * age 18 years or older * admitted with acute, decompensated heart failure * signed informed consent exclusion criteria: * approved by center for medicare and medicaid services (cms) to enroll in cardiac rehab * have an elective procedure that would interrupt their exercise program * unable to partake in an exercise program due to physical incapacities * pregnancy * unable to read and understand the consent form

Keywords: cardiac rehab heart failure kccq 6 minute walk test readmission
efficacy of epsw plus hilt on carpal tunnel syndrome post burn injury

Conditions: Burn Injury

Summary: to study the effect of adding eswt as a noninvasive short-term treatment plus high-level laser therapy for moderate carpal-tunnel syndrome post-burn injuries.

to study the effect of adding eswt as a noninvasive short-term treatment plus high-level laser therapy for mild to moderate carpal tunnel syndrome post-burn injuries. the effects of combining epsw with high-intensity laser therapy for improving pain, symptoms and function of motion, muscle strength, and quality of life in inpatients with carpal tunnel syndrome post-burn injuries

Eligibility criteria:
inclusion criteria: * patients diagnosed with carpal tunnel syndrome after thermal burn injuries. * patients will be diagnosed with median nerve conduction study and phalen sign and tinel test. * patients age: 20 to 60 years exclusion criteria: * patients with severe (absent sensory or motor waves) and mild (sensory nerve latency \>3.5 ms at third digit) cts according to emg-ncv study. * conditions that could impact upon or impacted by outcome measures or laser intervention (e.g. hypothyroidism, cancer, active infection, pulmonary disease, acquired immunodeficiency syndrome, associated myopathy, myelopathy, history of neck and/or shoulder surgery, drugabuse, corticosteroids consumption, and pregnancy) * patients received continuous physical therapy or exercise during the previous two weeks or taking analgesic or anti-inflammatory drugs during the week prior to the baseline assessment

Keywords: extracorporeal shock wave therapy high intensity laser therapy carpal tunnel syndrome
safety and efficacy of autologous endothelial progenitor cell cd 133 for therapeutic angiogenesis

Conditions: Coronary Artery Disease; Refractory Angina

Summary: the purpose of this study is to determine whether transendocardial injections of autologous endothelial progenitor cells cd 133 is safe and feasible in patients with refractory angina.

the progenitor trial is a randomized, double-blinded, multicenter controlled trial including patients with canadian cardiovascular society angina classification (ccs): ii-iv and ischemic zones by spect but without any option for revascularization. primary endpoint was to assess the safety and feasibility of transendocardial injection of selected cd133+cells. all patients were treated for 4-days with granulocyte colony-stimulating factor and underwent apheresis. cd133+ cells were selected with clinimacs system and were injected transendocardially guided by the noga xp system.

Eligibility criteria:
inclusion criteria: * functional class ii- iv angina on maximal medical therapy * myocardial ischemia/viability demonstrated by a reversible perfusion defect by means imaging techniques * patients should not be amenable to any type of revascularization procedure (percutaneous or surgical) * signed informed consent exclusion criteria: * age \ 75 years. * atrial fibrillation. * lv thrombus * acute myocardial infarction in the last 3 months * an lv wall thickness of \<8 mm at the target site for cell injection * a history of malignancy in the last 5 years

Keywords: refractory angina
braf v600e mutations in papillary thyroid carcinoma

Conditions: Papillary Thyroid Carcinoma

Summary: the purpose of this study is to determine whether braf v600e mutation in our patients with papillary thyroid cancer has an association with poor prognosis.

papillary thyroid carcinoma (ptc) is the most common type of thyroid malignancy and braf v600e mutation is the most common genetic alteration identified in ptc, ranging from 25 to 80%, with the average rate about 45%. various studies demonstrated a relationship between braf v600e mutation and aggressive characteristics of the cancer, including the worse patient prognosis. but,there are no studies from turkey regarding this topic. so the investigators will examine braf v600e mutation in our patients with ptc and try to assess the role of this mutation in prognosis and further management of the patients.

Eligibility criteria:
inclusion criteria: * patients with papillary thyroid cancer exclusion criteria: * patients who do not want to be a part of this study

Keywords: papillary thyroid carcinoma braf v600e poor prognosis aggressive
modulation of serca2a of intra-myocytic calcium trafficking in heart failure with reduced ejection fraction

Conditions: Congestive Heart Failure; Heart Failure, Systolic; Heart Failure; HFrEF - Heart Failure With Reduced Ejection Fraction

Summary: it is believed that targeted serca2a enzyme replacement in hfref patients will correct defective intracellular ca2+ hemostasis, resulting in improved cardiac contractile function and energetics which will, in turn, translate to improved clinical outcomes. additionally, it is hypothesized that correcting serca2a dysfunction will also improve coronary blood flow through correction of the impaired endothelium-dependent nitric oxide-mediated vasodilatation observed in heart failure.

music-hfref1 is an interventional study of srd-001, an adeno-associated virus serotype 1 (aav1) vector expressing the transgene for sarco(endo)plasmic reticulum ca2+ atpase 2a isoform (serca2a), in anti-aav1 neutralizing antibody (nab) negative subjects with ischemic or non-ischemic cardiomyopathy and new york heart association (nyha) class iii/iv symptoms of heart failure with reduced ejection fraction (hfref). the phase 1 trial is an open-label, uncontrolled study investigating two doses of srd-001 at 3e13 and 4.5e13 viral genomes (vg) in 3-4 participants at each dose level. the phase 2 trial is a randomized, double-blind, placebo-controlled trial with prospective assignment to a single dose of either srd-001 or placebo in a 1:1 ratio and a total sample size of n=50.

Eligibility criteria:
main inclusion criteria: * chronic ischemic or non-ischemic cardiomyopathy * nyha class iii/iv * lvef ≤35% * guideline-directed medical therapy for heart failure; icd main exclusion criteria: * restrictive cardiomyopathy, hypertrophic cardiomyopathy, acute myocarditis, pericardial disease, amyloidosis, infiltrative cardiomyopathy, uncorrected thyroid disease or discrete left ventricular (lv) aneurysm * prior heart transplantation, left ventricular reduction surgery (lvrs), cardiomyoplasty, passive restraint device (e.g., corcap™ cardiac support device), mechanical circulatory support device (mcsd) or cardiac shunt * likely to receive cardiac resynchronization therapy, cardiomyoplasty, lvrs, conventional revascularization procedure or valvular repair in the 6 months following treatment * likely need for an immediate heart transplant or mcsd implant due to hemodynamic instability * inadequate hepatic and renal function * diagnosis of, or treatment for, any cancer within the last 5 years except for basal cell carcinoma or carcinomas in situ where surgical excision was considered curative
outcome following truncation of asparaginase

Conditions: Relapse Leukemia

Summary: this study aimed to investigate the outcome of patients who had their asparaginase treatment truncated in the nopho all2008 protocol.

overall survival for children with all is now above 90% in several protocols, but asparaginase associated toxicities still constitutes a significant problem as they, besides causing acute morbidity and mortality, can cause truncation of treatment with a subsequent increased risk of relapse. the most frequent toxicities causing asparaginase truncations are hypersensitivity, pancreatitis and thrombosis. especially hypersensitivity constitutes a problem due to silencing antibodies, not only in patients with clinical hypersensitivity but also in patients without clinical symptoms (silent inactivation). in the nopho all2008 protocol asparaginase associated toxicities and truncation of asparaginase have been registered since the protocol opened in 2008. in addition asparaginase enzyme activity measurements have been done before every asparaginase administration and analyzed retrospectively. the primary aim of this study was to investigate if patients with truncation of asparaginase or lack of asparaginase enzyme activity had a different risk of relapse compared to patients who received full asparaginase treatment. secondary we aimed to explore if patients who received less than 50% of their planned asparaginase dosages had a different risk of relapse compared to those who received 50% or more.

Eligibility criteria:
inclusion criteria: - children treated according to the nopho all2008 protocol from the 1st of july 2008 - 28th of february 2016. exclusion criteria: * bilineage all * pre-treatment with glucocorticosteroids or other antileukemic agents for more than 1 week * all predisposition syndromes * previous cancer * off protocol administration of additional chemotherapy during induction therapy * sexually active females not using contraception

Keywords: acute lymphoblastic leukemia asparaginase truncation toxicitities
genicular rft vs phenol management in patients with knee osteoarthritis

Conditions: Knee Pain Chronic

Summary: the aim of this study was to compare the efficacy of phenol and radiofrequency ablation for genicular nerve neurolysis in severe knee pain. the invesigators compare the efficacy of radiofrequency and phenol applications on numerical pain score and western ontario and mcmaster universi- ties osteoarthritis index (womac) before, 1 and 3 months after the procedure. the procedures will be performed by applying radiofrequency waves and phenol to the genicular nerves under ultrasound guidance.

ultrasound-guided genicular nerve ablation is a minimally invasive procedure that reduces or eliminates pain in patients with knee pain by destroying the nerves that transmit pain with heat or chemical drugs such as phenol. genicular nerve ablation is an effective treatment option for patients with chronic knee pain who cannot undergo prosthesis surgery. in this method, radiofrequency waves or phenol are applied to the nerves going to the knee joint, preventing the transmission of pain signals to the brain. the procedure is applied as follows: haemodynamic monitoring is provided. superomedial genicular nerve (smgs), superolateral genicular nerve (slgs), inferomedial genicular nerve (imgs) are the nerves to be blocked. the 8-12 hz linear ultrasound probe is first placed superomedial to the knee and the smgs and genicular artery are visualised at the junction of the shaft and condyle of the femur. the skin is locally anaesthetised with 2% lidocaine (2 cc) and the needle is inserted in plane with the ultrasound probe. for radiofrequency ablation the cannula placed close to the nerve is connected to the radiofrequency generator with the help of cables. at the tip of the needle, 2% lidocaine (1 cc) is administered and the nerve is heated by applying radiofrequency current. ablation is performed at 80 °c for 1 minute. this procedure is repeated for other genicular nerves. for phenol ablation, 1 ml of 7% phenol solution is applied to cause neurolysis with the help of a needle placed close to the nerve. phenol provides ablation by denaturing the proteins in the structure of the nerve. patients will be evaluated on nrs and womac scales before, 1 and 3 months after the procedure. the evaluation will be done face to face and by telephone call.

Eligibility criteria:
inclusion criteria: * moderate to severe knee pain due to knee osteoarthritis (0-10 pain of intensity 6 and above on an inter-numeric pain scale) * permanent pain for more than 6 months * grade 3 or 4 in the radiological kellgren-lawrence classification having osteoarthritis * pain with conservative methods such as analgesics and physiotherapy treatment failure exclusion criteria: * history of intra-articular knee intervention in the last 6 months * cognitive impairment * hepatic or renal insufficiency * severe psychiatric illness * local or systemic infection * coagulopathy

Keywords: genicular radiofrequency phenol pain treatment osteoarthritis
secukinumab (cosentyx®) effectiveness in axial spondyloarthritis and psoriatic arthritis patients using artificial intelligence (spainet): spanish multicenter, retrospective, real world evidence study

Conditions: Axial Spondyloarthritis; Psoriatic Arthritis

Summary: this was a multicenter, retrospective, and non-interventional study using secondary data captured in the electronic health records (ehrs). the extraction of the data captured in the ehrs was performed with ehread® by savana, an innovating data-driven system based on natural language processing (nlp) and big data analytics. data was extracted and analyzed at index date, follow up, or as specified for each variable.


Eligibility criteria:
inclusion criteria: * aged ≥ 18 years. * diagnosed with axspa or psa. * had received or are receiving bdmard, independently of the line of treatment, from january 2018 to data collection. * had at least 3 months follow up from first bdmard administration. * patients with ehrs. exclusion criteria: • receiving bdmard within a clinical trial from january 2018 to data collection.

Keywords: axial spondyloarthritis; psoriatic arthritis; electronic health records; natural language processing; artificial intelligence
a extension study to evaluate the safety, tolerability, and immunogenicity of ub-612 covid-19 vaccine

Conditions: COVID-19

Summary: this is an extension study to evaluate the safety, tolerability and immunogenicity of one booster dose of ub-612 covid-19 vaccine in adults who completed two vaccinations of ub-612 vaccine 10, 30, and 100 μg in v-122 study.

this is an extension study to evaluate the safety, tolerability and immunogenicity of one booster dose of ub-612 covid-19 vaccine in adults who completed two vaccinations of ub-612 vaccine 10, 30, and 100 μg in v-122 study. 60 subjects will receive one booster dose of ub-612 vaccines 100 μg with the same dose which was offered in phase ii study, at least 6 months after first vaccination. in this study, there will be 3 clinical visits. subjects will come to the clinics at day 1, day 15, and day 85.

Eligibility criteria:
* inclusion criteria 1. male or non-pregnant female who previously participated in and completed two vaccinations in the v-122 study. 2. women of childbearing potential and men must agree to practice medically effective contraception during study period. 3. able to understand the content and possible risks of informed consent and willing to sign the informed consent form (icf). 4. able to understand and agrees to comply with all study procedures and be available for all study visits. 5. ear temperature ≤ 38.0°c. 6. at screening visit, at least 6 months after first vaccination in the v-122 study. * exclusion criteria 1. female who is pregnant or positive in pregnancy test at screening visit. 2. female who is breast-feeding or plans to breastfeed within 90 days after booster vaccination. 3. any acute illness, as determined by the study investigator 3 days before booster vaccination. 4. prior administration of attenuated, nucleic acid (mrna or dna) or vectored vaccines in last 1 month before booster vaccination or expectation of such vaccines in the month after booster vaccination. 5. prior administration of subunit vaccine or inactivated vaccine in last 14 days before booster vaccination or expectation of receipt of such vaccines in the 14 days after booster vaccination. 6. any medical disease or condition that, in the opinion of the study investigator, may confound the results of the study or pose an additional risk to the subjects by their participation in the study. 7. previous exposure to sars-cov-2 or receipt of an investigational or eua vaccine product for the prevention of covid-19, mers or sars except ub-612. 8. subjects who take part in another clinical study, other than v-122 study, within 12 weeks prior to the day of informed consent. 9. prior administration of immunoglobulins and/or any blood products in last 4 months before booster vaccination. 10. prior chronic administration of immunosuppressant or corticosteroids, cytotoxic treatment in last 6 months before first vaccination.